GAMP Training Courses

GXP-compliance.png  

This highly interactive, course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems , may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a life cycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP® 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems, and the full system life cycle from concept to retirement.

Coming Soon  
data-integrity.jpg  

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

13 - 15 November 2017
Location: Manchester, UK
Register Now

4 - 6 December 2017
Location: Tampa, FL, USA
Register Now
Receive a complimentary copy of the ISPE GAMP® Guide: Records and Data Integrity
US$395 value!

 

data-integrity-thumbnail.JPG

annex-11.png  

This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

1 - 3 November 2017
Location: Tampa, FL, USA
Register Now

5 - 7 February 2017
Location: Tampa, FL, USA
Register Now
Receive a complimentary copy of the GAMP® A Risk-Based Approach to Compliant GxP Computerized Systems Guide
US$570 value!
 

GAMP-5-Cover_v100.png

Take advantage of ISPE's early registration discount for training courses to save hundreds while staying up to date on GAMP®.  Click on Register Now to view the savings!